NCT04527185

Effect of Endotoxin on Alcohol Consumption

Does Endotoxin Administration Increase Alcohol Consumption in Individuals With AUD?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

For this protocol, the investigators plan to collect pilot data to examine the effect of endotoxin on drinking behavior in the human laboratory.

Detailed description

This pilot study is a double-blind, placebo-controlled design, which will compare endotoxin (0.4ng/kg i.v.) to placebo (0.0ng/kg) in non-treatment seeking adults meeting criteria for DSM-5 alcohol use disorders (n=32 total, n=16 per group). Eligibility screening consists of an intake session and a physical exam. Participants meeting eligibility criteria will be randomized to receive a single dose of 0.4ng/kg i.v. endotoxin or placebo during a single laboratory session to evaluate ad-libitum alcohol consumption. During the laboratory session, endotoxin (or placebo) administration will precede a 2-hour alcohol self-administration period. Participants will be scheduled for a follow-up appointment to evaluate drinking behavior. Adverse events are evaluated during the laboratory session and follow-up, and will be tabulated.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Endotoxin	Endotoxin 0.4ng/kg i.v.

Timeline

• Start date: 2022-02-27
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2020-08-26
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study